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    Share Your Voice With the FDA to Impact Drug Development and Safety

    public health

    By John Whyte, MD, MPH

    As a physician and a regulator, I’ve come to realize that patients are valuable experts in their own medical conditions. That’s why the FDA wants to hear patients’ unique perspectives on the treatments they receive to help make more informed decisions about different drug products. Ultimately, sharing your voice can benefit the FDA’s goal of improving the safety and effectiveness of drugs.

    That’s one of the reasons why the FDA launched a new online system to make it easier to request a meeting on drugs with the scientists and staff who review and regulate them. The request process begins at www.FDA.gov/RequestAMeetingOnDrugs. All you have to do is enter some basic information about the purpose of your meeting, then click submit. We will help you coordinate a meeting with FDA’s experts or find the information you need.

    Meetings offer an important avenue for patients, advocacy groups, health care professionals, and other stakeholders to express how conditions and medications impact them or their patients. Although the FDA has been meeting with patients and other stakeholders on topics related to drugs for almost 30 years, a user-friendly avenue for members of the public to ask for a meeting has never existed until now.

    By streamlining the meeting request process, we hope to gain a deeper understanding of how a disease impacts the people who have it and what their values and preferences are. It is important to engage with patients to truly understand what is clinically meaningful to them.

    I look forward to hearing from you.

    John Whyte

    John Whyte, MD, MPH, is the Director of Professional Affairs and Stakeholder Engagement for the FDA’s Center for Drug Evaluation and Research.

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